Disposable Disc Filter
510(k) K936015
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK936015 | Date12 Dec 1994 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FMF
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Disposable Disc Filter is a sterile, single-use filtration device designed to retain bacteria and particles down to 0.2 microns. It functions as a barrier in fluid pathways, ensuring contamination-free sterilization and fluid transfer in medical and laboratory applications.
Supplied in packs of 50, these hydrophilic and bi-directional filters feature proximal and distal luer locks (male and female) for secure attachment to luer-connection systems. Intended for hospital use, they maintain sterility by preventing splashes and leaks during fluid administration or filtration processes. The device holds an FDA 510(k) clearance under product code FMF, with K-number K936015.
Other devices from Medi-Dose, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of medical or laboratory applications is this filter designed for, and why is it considered single-use?
The Disposable Disc Filter is designed for hospital use in fluid pathways where contamination-free sterilization and filtration are critical, such as during fluid administration or filtration processes. It is considered single-use because its sterile packaging and hydrophilic, bi-directional design are intended for one-time use only to prevent bacterial or particulate contamination from reuse. Using it more than once could compromise sterility and compromise the integrity of the filtration process.
How are these filters packaged and supplied, and what does the packaging ensure?
The filters are supplied in packs of 50, each unit individually sterile and ready for immediate use. The packaging ensures sterility by preventing splashes, leaks, and contamination during storage and handling, which is essential for maintaining the integrity of the filtration process in medical or laboratory settings.
What sizes or models are available for the Disposable Disc Filter, and how do the luer locks help with secure attachment?
The data provided does not specify exact sizes or model variations beyond the standard design, but the filters feature proximal and distal luer locks (male and female) for secure attachment to luer-connection systems. This ensures a tight seal during fluid transfer, reducing the risk of leaks or contamination in medical or laboratory applications.
Is this filter reusable, and if not, what happens to the filter after use?
No, the Disposable Disc Filter is explicitly designed for single-use only. After use, the filter should be discarded in accordance with medical waste disposal protocols to prevent cross-contamination and maintain infection control standards in healthcare settings.
How does the FDA clearance (K936015) under product code FMF relate to the intended use of this device?
The FDA clearance under product code FMF (General Hospital Products) and K-number K936015 confirms that the Disposable Disc Filter is classified as a General Hospital device and has been determined substantially equivalent to a predicate device. This clearance does not describe its clinical indication but rather confirms its regulatory classification for use in hospital settings where filtration and contamination control are required, such as in fluid administration systems.